[ad_1]
Adalimumab biosimilar SB5 has been reported to be as safe and effective as reference products in randomized controlled trials and reviews of real-world studies on immune-mediated inflammatory diseases. The quality of the product was stable over time, there were no fluctuations in bioactivity, and both patients and healthcare professionals preferred his SB5 injection device over other devices.
Adalimumab is a monoclonal antibody that targets tumor necrosis factor (TNF) alpha, a proinflammatory cytokine involved in the development of several autoimmune and inflammatory diseases. Adalimumab was first approved by the US FDA in 2002. Currently, rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), psoriasis, Crohn’s disease (CD), ulcerative colitis (UC), suppurative Hidradenitis (HS), uveitis. The main patent for reference adalimumab (Humira) expired in 2016, and adalimumab biosimilars, including SB5 (Hadrima/Imuradi, Samsung Bioepis), entered the US market for the first time in 2023.
Image credit: Davizro Photography – Stock.adobe.com
This review summarized the randomized controlled trials supporting the approval of SB5 and provided an overview of the real-world data available after approval. Adalimumab SB5 was approved in the European Union in 2017 and in the United States in 2019, based on evidence including controlled clinical trials in patients with rheumatoid arthritis. That approval was extended by extrapolation to additional indications including JIA, psoriasis, PsA, AS, CD, UC, and HS. A Phase 4 study of SB5 in patients with plaque psoriasis is underway to support compatibility with the reference product.
SB5 is available as both a low concentration formulation with citrate and a high concentration formulation without citrate. Comparable pharmacokinetic parameters between low-concentration SB5 and reference adalimumab were demonstrated in clinical studies in healthy subjects and confirmed in comparative efficacy studies. Subsequent studies found that his SB5 formulation, which does not contain high concentrations of citrate, had pharmacokinetics comparable to lower concentration formulations. The authors write that in randomized controlled trials, there was “no clinically meaningful difference” in safety, comparable efficacy, and comparable immunogenicity between SB5 and the reference product.
Real-world research: SB5 is as effective as the reference product and poses no new safety concerns
The reviewers concluded that the real-world data “confirm the results of randomized clinical trials conducted in controlled settings and are not sufficient to extrapolate approval of biosimilars for use in the indications held in the literature.” “It is an important means of providing data.” product. ” This pivotal comparative clinical trial was conducted in patients with moderate to severe rheumatoid arthritis. The actual study included RA, AS, PSA, inflammatory bowel disease (IBD), psoriasis, HS, Additional data on the use of SB5 in inflammation are provided and “confirm the efficacy and safety of SB5,” the authors said.
Actual observational studies have investigated SB5 in both adalimumab-naïve and experienced patients. Overall, the real-world study found that SB5 was “comparable to the reference product in a variety of indications and countries, treatment continuity was maintained well throughout the study, and no new safety concerns were identified.” did.”
Observational studies such as the PROPER study, which collected 48 weeks of data on patients with inflammatory arthritis or IBD (CD or UC) who switched from a reference product to SB5, found that treatment effects were “maintained throughout the study” .
The reviewers noted that injection site pain was observed more frequently with SB5 treatment compared to the reference product in multiple studies, and these observational studies used lower concentrations of SB5 formulations containing citrate. It added that it was carried out. Multiple factors can contribute to injection site pain, the researchers said, including pH, volume, excipients, and injection equipment. A clinical equivalence study comparing the two formulations found a lower incidence of injection site reactions with the citrate-free, higher concentration formulation (4% vs. 11%).
Product quality remains stable over time
Because biologics are produced by living organisms, different manufacturing lots of biologics can have different quality characteristics from each other, the authors said, and these variations must be accounted for to ensure efficacy and safety. It added that it was important to monitor and minimize it. According to the authors, SB5’s manufacturing process and quality characteristics have been “strictly controlled and monitored since the start of production.” They cited analysis of 93 batches of SB5 and showed that TNF binding and neutralization capacity was comparable between batches, ranging from 86% to 108% and 89% to 119%. Key quality attributes have been consistent over time and are “well within the acceptable range of variation” recommended by regulators.
Patients and healthcare professionals prefer the SB5 injection device
The SB5 injection pen differs from the reference adalimumab injection pen in its shape, non-slip surface, and smaller needle gauge. The initiation mechanism eliminates the need to press the thumb trigger button and provides an audible “click” indicator at the beginning and end of each dose. An enlarged drug display window allows the patient to confirm that the entire dose has been injected. The reviewer cited his two research studies that compared the SB5 injection device to an adalimumab reference product or an etanercept reference product injection device. In both of these studies, most patients (78%-79%) and nurses (85%-86%) preferred their SB5 device.
The reviewers found that available data support the safety and efficacy of SB5 across adalimumab indications, that switching from the reference product to SB5 is “feasible” and that patients and medical professionals Both homes prefer the SB5 injection device over other devices, and the high concentration of citrate-free SB5 may reduce the incidence of injection site pain.
reference
Kay J, Cross RK, Feldman SR et al. Review of adalimumab biosimilar SB5 in immune-mediated inflammatory diseases. advance stel. 2024;41:509-533. doi:10.1007/s12325-023-02737-1
[ad_2]
Source link
